FDA: Page 32
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Risk-based quality management: Your key to safety and effectiveness
Why is the FDA and other regulators urging clinical trial sponsors to rethink the way they design and run clinical trials?
Jan. 9, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA approval decisions to watch in the 1st quarter
Aimmune's peanut allergy therapy and Esperion's cholesterol offering could be among the new drugs cleared in the first few months of the new decade.
By Jacob Bell • Jan. 2, 2020 -
AstraZeneca and Merck's Lynparza cleared by FDA for pancreatic cancer
The pill is the second targeted treatment approved for pancreatic cancer, although its use is limited to only a small share of patients.
By Jonathan Gardner • Dec. 30, 2019 -
Intra-Cellular approval keeps focus on FDA's neuroscience review process
Lumateperone, to be sold as Caplyta, had conflicting results in late-stage trials. Its approval suggests the FDA is using a "glass half full lens" to review neuroscience drugs, said one analyst.
By Jacob Bell • Dec. 23, 2019 -
FDA rejects GSK's HIV therapy in setback to two-drug strategy
The British drugmaker said the Complete Response Letter was unrelated to product safety, but the delay could hamper GSK's bid to challenge rival Gilead.
By Andrew Dunn • Dec. 23, 2019 -
Daiichi, AstraZeneca breast cancer drug joins bumper crop of early FDA approvals
AstraZeneca bet big on the Japanese pharma's HER2-targeting therapy, a gamble that paid off with a speedy approval for Enhertu.
By Jonathan Gardner • Updated Dec. 23, 2019 -
FDA approves Merck's Ebola vaccine, a historic first against deadly virus
The pharma giant has already given 275,000 doses of the vaccine to fight an outbreak in central Africa. Other drugmakers, including J&J and Regeneron, are also developing vaccines.
By Andrew Dunn • Dec. 20, 2019 -
Amarin secures long-sought FDA nod, boosting sales hopes for heart pill
The company will target as many as 80,000 doctors with a doubled salesforce for Vascepa, CEO John Thero said Monday in an interview.
By Andrew Dunn • Updated Dec. 16, 2019 -
Jacob Bell/BioPharma Dive
Biogen's Alzheimer's drug gets caught in Sarepta's spotlight
The unexpected approval of Sarepta's Vyondys 53 has some wondering how lenient the FDA might be in reviewing aducanumab. Others, however, see little impact.
By Jacob Bell • Dec. 13, 2019 -
Hahn confirmed as FDA head, to lead agency as drug review process is tested
Stephen Hahn, an oncologist and former MD Anderson executive, is set to confront several pressing issues, including the rigor of the FDA's approvals.
By David Lim , Andrew Dunn • Dec. 13, 2019 -
In stunning twist, FDA approves Sarepta's Duchenne drug it rejected
Following an August rejection of Vyondys 53, Sarepta appealed the FDA's decision through a formal dispute resolution process that led to the agency's about-face.
By Ned Pagliarulo , Jonathan Gardner • Dec. 12, 2019 -
New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda
One Wall Street analyst expects the FDA's OK will help Tecentriq outpace Bristol-Myers Squibb's Opdivo in 2020 in the non-small cell lung cancer market.
By Jonathan Gardner • Dec. 4, 2019 -
Trump FDA nominee Hahn advanced by Senate HELP Committee
Senators voted 18-5 to move Hahn's nomination to a full Senate vote. Sen. Patty Murray cited concerns over Hahn's position on e-cigarettes in voting no.
By David Lim • Dec. 3, 2019 -
After FDA rejection, Immunomedics tries again with breast cancer drug
Sacituzumab govitecan would be Immunomedics' first commercial product if the biotech succeeds on its second attempt to convince the FDA.
By Andrew Dunn • Dec. 3, 2019 -
FDA denies Lexicon bid to reverse diabetes drug rejection
The biotech, which lost big pharma partner Sanofi earlier this year, isn't giving up, announcing plans to escalate its dispute to a higher division within the FDA.
By Ned Pagliarulo • Dec. 2, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Before 2019 closes, the FDA has 3 key approval decisions to make
The agency has been on an approval tear lately, and more may come as reviews for drugs from Amarin, Allergan and Intra-Cellular wrap up.
By Jacob Bell • Nov. 27, 2019 -
Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo
A list price of roughly $10,000 a month puts Global Blood's Oxbryta slightly higher than what Novartis' Adakveo will cost.
By Jonathan Gardner • Updated Nov. 26, 2019 -
FDA approves new epilepsy therapy, a first for Korea's SK Life Science
The Korean drugmaker has steadily grown its U.S. pharmaceutical presence over the past decade, now capped by an OK for Xcopri.
By Andrew Dunn • Nov. 22, 2019 -
Calquence OK boosts AstraZeneca's challenge to Imbruvica
The new FDA approval expands Calquence's use into a more common blood cancer, although doctors have already been prescribing it for that disease.
By Jonathan Gardner • Nov. 22, 2019 -
Novartis sickle cell drug wins FDA approval
Adakveo is only the second treatment approved in two decades for the painful blood clots caused by the rare disease.
By Jonathan Gardner • Nov. 15, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
BeiGene FDA cancer drug nod seen as breakthrough for Chinese biopharma
The drug, branded as Brukinsa, will go up against J&J and AbbVie's Imbruvica and AstraZeneca's Calquence in lymphoma.
By Jonathan Gardner • Nov. 15, 2019 -
FDA expert panel unanimously recommends Amarin's Vascepa in closely-watched vote
Debates about side effects and the mineral oil placebo failed to dissuade any member of the FDA's advisory committee from voting against an expanded indication.
By Andrew Dunn • Nov. 14, 2019 -
Jacob Bell/BioPharma Dive
Mylan plant warned by FDA over valsartan manufacturing
Regulators said Mylan's ways of identifying, testing and handling raw materials at an Indian plant aren't enough to prevent contamination.
By Kristin Jensen • Nov. 14, 2019 -
Jacob Bell/BioPharma Dive
FDA documents appear to clear Amarin path to wider heart drug approval
The documents, released ahead of Thursday's advisory panel meeting, suggest the FDA is open to an expanded label for Vascepa, Amarin's fish oil-derived pill.
By Ned Pagliarulo • Nov. 12, 2019 -
FDA
Regenxbio, stung by trial hold on gene therapy, sues FDA
The biotech seeks to overturn clinical holds placed by the FDA on two gene therapy programs, arguing the agency action was "arbitrary and capricious."
By Ned Pagliarulo • Nov. 11, 2019
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